Table 5.
Complications post-procedures during follow-up period.
Study Author (Year) | Turagam-HFIB 2 (2021) [22] | Turagam-HFIB 1 (2021) [22]a | Steinberg et al., (2020) [21] | Kiuchi et al., (2018) [20] | Kiuchi et al., (2017) [19] | Kiuchi et al., (2016) [18] | Pokushalov et al., (2014) [17] | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Study groups | PVI + RDN | PVI | PVI + RDN | PVI | PVI + RDN | PVI | PVI + RDN | PVI + Spironolactone | PVI + RDN | PVI | PVI + RDN | PVI | PVI + RDN | PVI |
Femoral venous vascular events | 2/28 | 0/22 | 0 | 1/17 | 6/154 | 4/148 | 0 | 0 | 0 | 0 | 0 | NR | 0 | 0 |
Transient phrenic nerve plasty | 0 | 0 | 0 | 0 | 1/154 | 1/148 | 0 | 0 | 0 | 0 | 0 | NR | 0 | 0 |
Cardiac tamponade | 0 | 0 | 0 | 0 | 0/154 | 1/148 | 0 | 0 | 0 | 4/?b | 0 | NR | 1/41 | 0 |
Pneumothorax | 0 | 0 | 0 | 0 | 0/154 | 1/148 | 0 | 0 | 0 | 0 | 0 | NR | 0 | 0 |
Hospitalization | 0 | 0 | 0 | 0 | 8/154 | 18/148 | 0 | 0 | 0 | 0 | 0 | NR | 0 | 0 |
Death | 0 | 0 | 0 | 0 | 2/154 | 2/148 | 0 | 0 | 0 | 0 | 0 | NR | 0 | 0 |
Stroke | 0 | 0 | 0 | 1/17 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NR | 0 | 0 |
Renal artery stenosis | 0 | 0 | 3/13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NR | 0 | 0 |
Renal artery dissection in procedure | 0 | 0 | 3/13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NR | 0 | 0 |
Total | 2/28 | 0/22 | 6/13 | 2/17 | 17/154 | 27/148 | 0 | 0 | 0 | - | 0 | NR | 1/41 | 0 |
Data reported as number of events over sample size.
PVI pulmonary vein isolation, RDN renal denervation, NR not reported.
aThis study was terminated early due to a high rate of renovascular complications.
bFour cardiac tamponade events were reported in this study, but it was not clear which PVI group this occurred in.